Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

Approval Order StatementAPPROVAL FOR CHANGES TO THE SOFTWARE OF THE EXABLATE SYSTEM INCLUDING ENABLING MOVEMENT OF THE TRANSDUCER IN THE ANTERIOR AND POSTERIOR DIRECTION. THE MODIFIED DEVICE IS REFERRED TO AS THE EXABLATE 2100 V1.1 WITH SOFTWARE VERSION 6.5.